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EUDAMED last updated this device on May 28, 2026
084535700678AP[0678L] LYFO DISK™ E. hirae ATCC 10541™ is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Microbiologics, INC.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
10845357016048[0678L] LYFO DISK™ E. hirae ATCC 10541™(01)10845357016048
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01040601QC STRAINS BACTERIOLOGY1 warning recorded — scroll inside the panel to see all entries.
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
US-MF-000000466The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
084535700299ABOn the market[01269L] LYFO DISK™ B. cenocepacia ATCC BAA-245™0845357001269X6On the market[0681K] KWIK-STIK™ E. coli ATCC 11229™084535700681ACOn the market[0320P] KWIK-STIK™ B. fragilis ATCC 25285™08453570032099On the market[0975L] LYFO DISK™ P. aeruginosa ATCC 35032™084535700975AYOn the market[0250U] KWIK-STIK™ C. albicans ATCC 90029™0845357002509DOn the market